The objective of this acute study was to investigate the safety and efficacy of UClear for the resolution of urinary tract infection (UTI) symptoms in women. The main questions it aims to answer is: 1. Is there a difference in proportion of participants with complete resolution of UTI symptoms at Day 4 between UClear and placebo 2. Is there a difference in change from baseline (Day 1) at Day 4 between UClear and placebo in Urinary Tract Infection Symptom Assessment (UTISA) symptom severity scores. Participants will take UClear or placebo twice a day for 3 days with or without food, have 4 in clinical visits, and will be instructed to complete a quality of life (QoL) questionnaire during each visit and a UTISA questionnaire at follow-up (Day 7).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Take one dose twice a day for three days with or without food, starting on Day 1 (baseline visit).
Take one dose twice a day for three days with or without food, starting on Day 1 (baseline visit).
KGK Science Inc.
London, Ontario, Canada
The difference in proportion of participants with complete resolution of UTI symptoms at Day 4 between D-mannose and placebo
The difference in proportion of participants with complete resolution of UTI symptoms at Day 4 between D-mannose and placebo as defined as 0 points on all UTISA questionnaire components.
Time frame: Day 1 to 4
The difference in change between D-mannose and placebo in UTISA symptom severity scores
The difference in change from baseline (Day 1) at Day 4 between D-mannose and placebo in the frequency of urination
Time frame: Day 1 to 4
The difference in change between D-mannose and placebo in UTISA symptom severity scores
The difference in change from baseline (Day 1) at Day 4 between D-mannose and placebo in urgency of urination
Time frame: Day 1 to 4
The difference in change between D-mannose and placebo in UTISA symptom severity scores
The difference in change from baseline (Day 1) at Day 4 between D-mannose and placebo in painful/burning urination
Time frame: Day 1 to 4
The difference in change between D-mannose and placebo in UTISA symptom severity scores
The difference in change from baseline (Day 1) at Day 4 between D-mannose and placebo in incomplete voiding
Time frame: Day 1 to 4
The difference in change between D-mannose and placebo in UTISA symptom severity scores
The difference in change from baseline (Day 1) at Day 4 between D-mannose and placebo in pelvic pain
Time frame: Day 1 to 4
The difference in change between D-mannose and placebo in UTISA symptom severity scores
The difference in change from baseline (Day 1) at Day 4 between D-mannose and placebo in blood in urine
Time frame: Day 1 to 4
The difference in proportion of participants with complete resolution of UTI symptoms between D-mannose and placebo
The difference in proportion of participants with complete resolution of UTI symptoms between D-mannose and placebo at Day 2
Time frame: Day 1 to 2
The difference in proportion of participants with complete resolution of UTI symptoms between D-mannose and placebo
The difference in proportion of participants with complete resolution of UTI symptoms between D-mannose and placebo at Day 3
Time frame: Day 1 to 3
The difference in the change in symptom severity scores from baseline between D-mannose and placebo
The difference in the change in symptom severity scores from baseline between D-mannose and placebo as assessed by UTISA questionnaire at Day 2
Time frame: Day 1 to 2
The difference in the change in symptom severity scores from baseline between D-mannose and placebo
The difference in the change in symptom severity scores from baseline between D-mannose and placebo as assessed by UTISA questionnaire at Day 3
Time frame: Day 1 to 3
The difference in the change in UTISA bother scores from baseline between D-mannose and placebo
The difference in the change in UTISA bother scores from baseline between D-mannose and placebo as assessed by UTISA questionnaire at Day 2
Time frame: Day 1 to 2
The difference in the change in UTISA bother scores from baseline between D-mannose and placebo
The difference in the change in UTISA bother scores from baseline between D-mannose and placebo as assessed by UTISA questionnaire at Day 3
Time frame: Day 1 to 3
The difference in the change in UTISA bother scores from baseline between D-mannose and placebo
The difference in the change in UTISA bother scores from baseline between D-mannose and placebo as assessed by UTISA questionnaire at Day 4
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Time frame: Day 1 to 4
The difference in change in urine culture (multiple bacterial strains) from baseline between D-mannose and placebo
The difference in change in urine culture (multiple bacterial strains) from baseline between D-mannose and placebo at Day 2
Time frame: Day 1 to 2
The difference in change in urine culture (multiple bacterial strains) from baseline between D-mannose and placebo
The difference in change in urine culture (multiple bacterial strains) from baseline between D-mannose and placebo at Day 3
Time frame: Day 1 to 3
The difference in change in urine culture (multiple bacterial strains) from baseline between D-mannose and placebo
The difference in change in urine culture (multiple bacterial strains) from baseline between D-mannose and placebo at Day 4
Time frame: Day 1 to 4
The difference in change of quality of life from baseline between D-mannose and placebo
The difference in change of quality of life from baseline between D-mannose and placebo assessed by the RAND SF-36 questionnaire at Day 2
Time frame: Day 1 to 2
The difference in change of quality of life from baseline between D-mannose and placebo
The difference in change of quality of life from baseline between D-mannose and placebo assessed by the RAND SF-36 questionnaire at Day 3
Time frame: Day 1 to 3
The difference in change of quality of life from baseline between D-mannose and placebo
The difference in change of quality of life from baseline between D-mannose and placebo assessed by the RAND SF-36 questionnaire at Day 4
Time frame: Day 1 to 4
The difference in proportion of participants taking rescue medication up to Day 4 and/or during the follow-up period between D-mannose and placebo
Time frame: Day 1 to 7